Industry Ready QA/QC Online Training Program With Project Work & Placement Assistance

Approximately 65% of jobs in the pharmaceutical and biotech industries require QA/QC expertise.

Freshers with QA/QC skills are 2x more employable in the industry.

Not Just Training – We Train You Like You’re Already on the Job!

STARTS 27th NOV 2025

GET HANDS-ON TRAINING + PROJECT WORK + PLACEMENT ASSISTANCE

Step into the world of Quality Assurance & Quality Control, the backbone of biotech, pharma, and regulated industries. Learn the skills, tools, and compliance know-how that ensure safety, precision, and trust in every product released to the world.

This program blends deep theoretical understanding with hands-on, real-world simulated projects, so you don’t just learn QA/QC, you live it, practice it, and master it before stepping into your first role.

Program Details:

• Date: 27th Nov 2025
• Time: 7:00 to 8:00 PM IST
• Mode: Online
• Duration: 45 days
• Project Duration: 1 Month project + Mock Interview

Eligibility:

• Education: B.Sc./M.Sc/B.Tech./M.Tech. in Biotechnology, Microbiology, Biochemistry, Life Sciences, Pharmacy, Food Technology, Chemistry, or related disciplines.

• Professionals: Current QA/QC, R&D, Production, or Regulatory professionals looking to upskill.

• Freshers: Graduates aiming to secure QA/QC roles with a practical edge.

• Note: Basic lab knowledge recommended; no prior QA/QC work experience required.

Download Brochure - Contains Course Modules, Project & Guide Details 

Check The Detailed Course Module & PROJECT DETAILS Below:

Module 1: Core Fundamentals of QA and QC

• Day 1 – Introduction to QA & QC
  Sub topics: Definitions, scope, importance, QA vs. QC: Distinctions and roles, Lifecycle approach to quality (hints about what types to expect in various industries like Biologicals, pharma, Diagnostic Labs, Medical Devices)

• Day 2 – Quality Systems and Concepts
  Sub topics: Quality policies, objectives, and manuals, SOPs (Standard Operating Procedures), Change control, deviations, CAPA

• Day 3 & Day 4 – Documentation Practices
  Sub topics: Good Documentation Practices (GDP), Data integrity (ALCOA+ principles), Record keeping and electronic documentation (21 CFR Part 11), Digital documentation tool – Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN)

• Day 5 – Sampling and Specification Setting
  Sub topics: Sampling techniques and acceptance criteria, Control charts and statistical sampling

• Day 6 – Batch Record Review
  Sub topics: Master batch records, Line clearance and in-process checks

Module 2: Analytical Methods in QA/QC Labs

• Day 7 & Day 8 – Basic Instrumentation in QC Labs
  Sub topics: Spectrophotometry, pH meters, balances, HPLC, GC, UV-Vis, FTIR, AAS (brief overview), ELISA, PCR (in biotech-specific QC), Micropipettes

• Day 9 – Analytical Method Validation
  Sub topics: Accuracy, precision, specificity, LOD, LOQ, System suitability testing

• Day 10 – Calibration and Maintenance
  Sub topics: Calibration protocols and logs, Instrument qualification (IQ, OQ, PQ)

• Day 11 – Microbiological Quality Control
  Sub topics: Sterility testing, bioburden, endotoxin testing, Environmental monitoring (air, surface, personnel)

Module 3: Regulatory Guidelines & Quality Standards

• Day 12 – Good Manufacturing Practices (GMP)
  Sub topics: WHO, US FDA, EU GMPs, Facility and personnel requirements, Material management and quality risk management

• Day 13 – Good Laboratory Practices (GLP)
  Sub topics: OECD principles, Study plans, raw data, archives

• Day 14 – ISO Standards Overview
  Sub topics: ISO 9001: Quality Management Systems, ISO 13485: Medical device QA, ISO 17025: Testing/calibration labs, ISO 22000/HACCP: Food safety, ISO 15189:2012 – Medical Laboratory testing

• Day 15 – ICH Guidelines
  Sub topics: ICH Q8–Q10 (Quality by Design, Risk Management)

• Day 16 – Emerging Regulatory Trends and Future-Ready Compliance
  Sub topics: New Product Categories & Pathways (mRNA based products, biosimilars, etc), Regulatory Adaptations for Digital Technologies (AI/ML in diagnostics or QC: FDA’s GMLP (Good Machine Learning Practice), Data integrity in cloud-based LIMS/QMS: Updated 21 CFR Part 11), Sustainable Biotech & Global Harmonization (Regulatory initiatives supporting green biomanufacturing, WHO/Codex efforts for bioengineered food safety, ICH Q12/Q14 for lifecycle and analytical procedure management)

Module 4: Industry-Specific QA/QC Modules

• Day 17 & Day 18 – Pharmaceutical Industry
  Sub topics: GMP implementation in drug manufacturing, In-process and finished product QC, Raw material and packaging material testing, Regulatory expectations (US FDA, CDSCO, EMA), Case: Batch rejection due to OOS results

• Day 19 & Day 20 – Biotechnology Industry
  Sub topics: QA in upstream and downstream processing, Biologics and biosimilars QC (potency, purity, sterility), Cell line validation, contamination control, Biosafety levels and documentation practices, Case: Failure investigation in monoclonal antibody production

• Day 21 & Day 22 – Food and Beverage Industry
  Sub topics: HACCP-based quality assurance, Shelf-life and sensory testing, Microbiological QC (TVC, yeast/mold, pathogens), Food labelling QA (FSSAI compliance), Case: Product recall due to allergen mislabelling

• Day 23 & Day 24 – Cosmetics and Personal Care
  Sub topics: Stability and preservative efficacy testing, Microbial testing of finished products, Dermatological safety claims and claim substantiation, Regulatory guidance (BIS, EU Cosmetics Regulation), Case: Non-compliance in SPF claim validation

• Day 25 & Day 26 – Medical Devices
  Sub topics: Comprehensive study of Quality Control and Quality Assurance systems in the medical device industry, emphasizing ISO 13485, 21 CFR Part 820, and EU MDR compliance. Includes detailed analysis of FDA and EMA regulatory expectations, CAPA systems, validation protocols, risk management (ISO 14971), and audit readiness

• Day 27 & Day 28 – Clinical Research and CROs
  Sub topics: GCP (Good Clinical Practice) and ICH E6 compliance, QA in protocol design, monitoring, and data collection, QC of CRFs, source documents, and lab data, Audit trails and trial master file (TMF) integrity, Sponsor audits and regulatory inspections (FDA, EMA), Case: QA audit findings in Phase II trial documentation

• Day 29 – QMS in Technology Transfer
  Sub topics: Ensuring Consistency Through Quality Management Systems, Continuous Monitoring, Process Validation, Ensuring Reproducibility and Compliance, Regulatory Compliance, Enhancing Knowledge Transfer and Training

Module 5: Data Analytics & Statistical Software in QA/QC

• Day 30 & Day 31 – Control Charts Interpretation
  Sub topics: Real-time plotting of control charts (X-bar, R-chart, p-chart, etc.), Detection of trends, shifts, and patterns using control rules (e.g., Western Electric Rules), Process Capability Analysis (Cp, Cpk), Alerts for out-of-control conditions, Brief introduction of Tools used: Minitab, JMP, Python/R (with QC/stat packages), SPC modules in LIMS or ERP

• Day 32 & Day 33 – Method Validation (Analytical/Instrumental)
  Sub topics: Tools and Software: Minitab/JMP for ANOVA, regression, DoE, Excel (with statistical plug-ins) for basic calculations, Empower, Chromeleon (for chromatographic systems), Python libraries (e.g., statsmodels, scipy) for automation in R&D labs

• Day 34 & Day 35 – Trend Identification and Monitoring
  Sub topics: Trend charts and time-series analysis, Outlier detection (Grubbs' test, Boxplots), Pareto analysis for error contribution, Multivariate data analysis (PCA, clustering) for complex datasets (e.g., biotech QC)
  Tools: Power BI/Tableau for dashboarding and visualization, R/Python for custom analytics pipelines, LIMS-integrated analytics modules

• Day 36 – Predictive Quality Management
  Sub topics: Machine learning models for predicting batch quality or detecting early signs of deviation, AI-enabled root cause analysis (especially in Pharma 4.0 environments), Digital twins for process simulations

Module 6: Audits, CAPA, and Root Cause Analysis

• Day 37 – Types of Audits
  Sub topics: Internal vs. external audits, Audit preparation, execution, follow-up

• Day 38 – Non-conformance Management
  Sub topics: Types of non-conformities, Investigation processes

• Day 39 – CAPA (Corrective & Preventive Actions)
  Sub topics: Writing effective CAPAs, Monitoring effectiveness

• Day 40 – Root Cause Analysis Tools
  Sub topics: Fishbone diagram (Ishikawa), 5 Whys, Fault tree analysis, FMEA (Failure Modes and Effects Analysis)

Module 7: Seven QC Tools and Case Studies

• Day 41 & Day 42 – 7 Basic QC Tools
  Sub topics: Cause and effect diagram (Ishikawa), Check sheets, Control charts, Histograms, Pareto charts, Scatter diagrams, Flowcharts

• Day 43 – Application and Interpretation
  Sub topics: Case-based exercises, Real-life QA/QC problems from industry

Module 8: Scope and Career Prospects

• Day 44 – Key roles and responsibilities in QA/QC
  Sub topics: Entry-level, Mid-level and Senior-level positions, Salary expectations and range, Job market in India and World, Present and Future prospects

• Day 45 – Career Advancement Requirements in QA/QC
  Sub topics: Professional Development and Certifications (ASQ certifications, ISO 9001 Lead Auditor/Internal Auditor, FSSC 22000, etc), Guidelines for Developing a QA/QC Career Path

Project Titles & Details

1. Design a QA/QC SOP System for a Hypothetical Biotech Lab
   Objective: Draft Standard Operating Procedures (SOPs) for key lab processes.
   Deliverables: SOP document set, flowchart of QA documentation flow, and change control process.

2. Analytical Method Validation Mini-Project (In-Silico/Simulated)
   Objective: Simulate validation of an HPLC/UV method for a model compound.
   Deliverables: Method validation protocol (accuracy, precision, LOD, LOQ), mock results, validation report.

3. Control Chart Development and Interpretation
   Objective: Create and interpret control charts using sample QC data.
   Tools: Excel/Minitab/Python.
   Deliverables: X-bar/R-chart analysis, identification of trends/out-of-control points, recommendations.

4. Case Analysis: Root Cause and CAPA for a Hypothetical Deviation
   Objective: Investigate a mock batch failure or audit finding and design a CAPA.
   Deliverables: Root cause analysis (Fishbone/5 Whys), CAPA plan, and effectiveness check design.

5. Data Integrity Audit of a Hypothetical QC Data Set
   Focus Modules: Module 1 (Data Integrity, 21 CFR Part 11), Module 5 (Data Analytics, LIMS/ELN).
   Deliverables: Data Integrity Audit Report highlighting findings, recommended corrective actions, and preventative measures.

6. Environmental Monitoring Plan for a Cleanroom Facility
   Objective: Design a microbiological monitoring strategy for surfaces, air, and personnel.
   Deliverables: Sampling schedule, alert/action limits, documentation template.

7. Quality Audit Simulation Report
   Objective: Perform a mock internal quality audit for a biotech manufacturing unit.
   Deliverables: Audit checklist, audit report, identified non-conformances, and recommendations.

8. Statistical Process Control (SPC) Chart Analysis and Process Improvement Proposal
   Objective: Use a statistical software tool (even Excel with add-ins or online SPC calculators) to generate a control chart (e.g., X-bar and R chart). Analyze the chart for out-of-control conditions or trends, calculate process capability (Cp, Cpk), and propose specific recommendations for process improvement based on findings.
   Deliverables: Control charts with analysis, process capability report, and a proposal for process improvement.

9. Regulatory Compliance Assessment for a Novel Product Category
   Objective: Research the current regulatory landscape for an emerging product category. Identify key QA/QC challenges and regulatory considerations for bringing such a product to market.
   Deliverables: A research paper or presentation outlining the regulatory pathway, key QA/QC challenges, and recommendations for compliance for the chosen novel product.

10. Supplier Qualification Audit Checklist Development
    Objective: Select a raw material or service, and develop a comprehensive audit checklist based on relevant GMP/ISO principles for qualifying this supplier. The checklist should cover aspects like quality management system, facility, personnel, equipment, documentation, and specific material handling/testing.
    Deliverables: A detailed Supplier Qualification Audit Checklist with scoring criteria.

11. Implementation of a Quality Risk Management (QRM) Plan in a Biopharmaceutical Manufacturing Process
    Objectives:

    • Apply ICH Q9 principles to identify, assess, and control quality risks.

    • Demonstrate risk prioritization using tools like FMEA or HACCP.

    • Develop mitigation and control strategies for critical process steps.
      Deliverables:

    • QRM Plan including risk assessment tools and results

    • Risk control matrix with defined critical control points

    • Presentation/report aligning with ICH Q9 and FDA QRM expectations

12. Analytical Method Transfer and Validation Between Two QC Laboratories (e.g., R&D and Production lab of the same company / CDMO to a Biomanufacturer)
    Objectives:

    • Design a robust method transfer protocol per ICH Q2 (R2) and USP <1224>.

    • Evaluate comparability data using appropriate statistical tools.

    • Address challenges in inter-lab variability and regulatory compliance.
      Deliverables:

    • Transfer and validation protocol

    • Data analysis and acceptance criteria report

    • Gap analysis and CAPA recommendations if transfer fails

Why Join This Program?

• Industry-Aligned Skills: Learn QA/QC concepts mapped to GMP, GLP, ICH guidelines.

• Project-Centric Training: Apply skills through real-world inspired simulations.

• Expert Trainers: Learn from experienced QA/QC professionals.

• Career Advantage: Gain practical exposure that recruiters value.

• Work Experience Boost: Receive a project work certificate to enhance your resume.

Career Prospects

This course prepares you for high-demand QA/QC roles such as:

• Quality Assurance Officer/Executive

• Quality Control Analyst/Executive

• Regulatory Affairs Associate

• Validation Specialist

• Documentation Specialist

• GMP/GLP Compliance Officer

• QA/QC Auditor

Industries Hiring: Pharmaceuticals, Biotechnology, Food & Beverages, Medical Devices, Cosmetics, Research Labs, CDMOs.

Why Work on Projects?

• Hands-On Application: Move beyond theory to practical problem-solving.

• Interview-Ready Skills: Showcase completed projects as part of your portfolio.

• Industry Simulation: Understand documentation, compliance, and workflow just like in real companies.

• Confidence Boost: Gain clarity on actual QA/QC job responsibilities.
  

FAQs

1. Who can join this program?
Students or professionals from Biotechnology, Microbiology, Life Sciences, Pharmacy, Food Tech, Chemistry, and related fields.

2. Do I need prior QA/QC experience?
No. Basic lab knowledge is enough — the course is beginner-friendly.

3. What is the duration of the course?
45 days of training + 1 month of project work with mock interviews.

4. Will recordings be provided?
Yes, all sessions will be recorded and shared for later access.

5. What kind of projects will I work on?
Projects include SOP drafting, method validation, CAPA, SPC analysis, supplier audit checklist, QRM plan, and method transfer.

6. What career roles can I apply for after this course?
QA/QC Analyst, QA Officer, Regulatory Affairs Associate, Validation Specialist, Compliance Officer, Auditor.

7. Will I get a certificate?
Yes, you’ll receive both a Training Certificate and a Project Work Certificate if you have opted

8. For any support, whom can I contact?
Please write to us at cst@biotecnika.org or info@biotecnika.org